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Comparison of prone and supine position on oxygenation of patients with COVID-19 with acute hypoxemia treated using reservoir mask

Protocol summary

Study aim
Control of pulmonary involvement in the initial stages of COVID-19 and before reaching severe degrees of ARDS
Design
The randomized, controlled clinical trial, phase 3, will be conducted on 30 hospitalized patients with SARS with acute hypoxia. For randomization, at first stage, 30 spheres from one to 30 are considered and following that will be randomly divided into two equal parts, including P (prone) and group S (supine), and then the ball of each group are taken out and the intended sequence will be recorded
Settings and conduct
Eligible patients admitted to COVID-19 ward at Kosar hospital, Semnan are assessed after being in the position of peron and supine and returne to normal position. After three days of receiving the oxygen by reserve bag, ABG, ESR, CRP, PaO2 and FiO2 are checked and compared in the two groups.
Participants/Inclusion and exclusion criteria
30 patients with acute hypoxia and hospitalized for SARS-CoV-2. Inclusion criterion included patients admitted to the ward with SARS-CoV-2 whose diagnosis was confirmed by PCR test and acute hypoxemia based on PaO2/FiO2 between 150-300 and age between 18 and 70 years old. Exclusion criterion included respiratory arrest or unstable cardiorespiratory condition, inability to protect the airways, apnea, intolerance of prone position. facial and oral trauma at the last 2 weeks, pulmonary embolism in the last two years, pregnancy and systemic diseases including asthma, chronic obstructive pulmonary disease, heart failure, unstable angina pectoris exclude from study.
Intervention groups
In intervention group, patients who need to continuous oxygen therapy by reserve bag will be placed in a prone position for one hour, every three hours up to three days. In control group, patients who need to continuous oxygen therapy by reserve bag will be placed in a supine position .
Main outcome variables
Arterial blood oxygen saturation level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151020024625N12
Registration date: 2021-04-30, 1400/02/10
Registration timing: registered_while_recruiting

Last update: 2021-04-30, 1400/02/10
Update count: 0
Registration date
2021-04-30, 1400/02/10
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prone and supine position on oxygenation of patients with COVID-19 with acute hypoxemia treated using reservoir mask
Public title
Assessing of prone and supine position on oxygenation of patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed COVID-19 based on PCR test PaO2/FiO2 ratio between 150-300
Exclusion criteria:
Patient's intolerance of prone position Facial and oral trauma during the last 2 weeks Asthma and chronic obstructive pulmonary disease, Heart failure Unstable angina pectoris
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, at first stage, 30 spheres from one to 30 are considered and following that was randomly divided into two equal parts, including P (prone) and group S (supine), and then using a lottery container, the ball of each group was taken out and the intended sequence was recorded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ُSemnan University of Medical Sciences
Street address
Central office of Semnan University of Medical Sciences, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC. 1399.201

Health conditions studied

1

Description of health condition studied
Acute respiratory distress syndrome
ICD-10 code
R06.03
ICD-10 code description
Acute respiratory distress syndrome

Primary outcomes

1

Description
Improving arterial blood oxygenation
Timepoint
Every three hours up to three days
Method of measurement
Pulse Oximeter Blood Oxygen Saturation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who need to continuous oxygen therapy by reserve bag will be placed in a prone position for one hour, every three hours up to three days.
Category
Treatment - Other

2

Description
Control group: Patients who need to continuous oxygen therapy by reserve bag will be placed in a supine position .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mohammad Bahrami
Street address
Amin Avenue, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
351989995
Phone
+98 23 3142 2120
Email
bahramimohammad.k@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei MD
Street address
Central office of Semnan University of Medical Sciences, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researchman
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Basidj Boulevard, Amin Ave.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2252
Email
mehrdadzahmatkesh@semums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahboubeh Darban MD
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Basidj Boulevard, Amin Ave.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
dr.mdarban@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researchmen
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Basidj Boulevard, Amin Ave.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3141 2252
Email
mehrdadzahmatkesh@semums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Anonymised data will be offered.
When the data will become available and for how long
After publishing of final report
To whom data/document is available
Researcher who working in academic institutions
Under which criteria data/document could be used
Referees and competent people
From where data/document is obtainable
Contact with scientific responsible
What processes are involved for a request to access data/document
After verifying the applicant's position
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